BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA

    MDR report key: 2627272 · Received June 19, 2012

    Report

    Report Number
    MW5025914
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 19, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC
    Product Code
    LOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S TOTAL ARTIFICIAL HEART WAS MALFUNCTIONING AND IT WAS SWAPPED OUT FOR A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA SYNCARDIA TOTAL ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC SYNCARDIA TOTAL LV-070363L0309

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening